Nursing Simulation Process Assignment

Running head: NURSING SIMULATION
Discussion post- Jan Klein, RN
Name of the Student
Name of the University
Author Note

1NURSING SIMULATION
Introduction- Time and again it has been established that the five basic ethical
principles encompass beneficence, non-maleficence, and minimizing harm, not using
deceptive practice, obtaining informed consent, and maintaining confidentiality (Metcalf &
Crawford, 2016). As a clinical research coordinator (CRC), it is imperative to stand up to the
principal investigator under circumstances when the ethical standards of a research are being
violated. This activity will elaborate on a research simulation and will also elaborate on the
ethical principles of research.
Discussion- In the research simulation activity, I played the character of Jan Klein,
who was a registered nurse (RN) and the CRC. The clinical research was begun only after
taking informed consent from the participants, and on observing discrepancy in study subject
medical record, in addition to their clinical characteristics, the events were reported to the
supervisor, with the aim of preventing any kind of research misconduct. The first ethical
challenge was related to absence of an IRB approval for conducting the melanoma multi-
center trial. Under the regulations of the FDA, an IRB is a suitably established group that has
been officially nominated to evaluate and monitor biomedical research concerning human
subjects. In agreement with FDA guidelines, an IRB has the ability to approve, necessitate
alterations in (to secure endorsement), or reject research (Blackwood et al., 2015). Thus, IRB
approval was required in order to ensure that only systematically and ethically
legal research had been executed. On having questions about the research, efforts were also
taken to search them online, in order to resolve any queries about the purpose and
methodology of the research. Even when Wendy Casper, a patient, and her son wanted to
skip the procedure of giving informed consent, owing to poor health status, voluntary
agreement was only taken after the subject demonstrated adequate understanding about the
investigation and its risks (Wolf, Clayton & Lawrenz, 2018).

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Inclusion and exclusion criteria also form essential aspects of a research since they
produce reliable results by selecting prospective study participants (Nardi, 2018). Taking into
consideration the fact that it creates a dramatic impact on the research population, reporting
concern about two subjects not meeting the criteria, and persuading their elimination from the
research population was another ethical procedure. It was also found that six participants
withdrew from the research. Without fabricating the data through addition of observations or
characterizations, allowing free withdrawal was another step that provided absolute or
unconditional removal rights, without providing any reason. Falsification of data is a
common ethical concern that involves omission or alteration of research results to support
hypotheses and claims (Jensen et al., 2018). On encountering such an instance, steps were
taken to report the incident to Dr. Rosenberg, who conducted an audit and also suspended all
kinds of work, unless the issue was resolved. This audit helped in determining compliance to
the statutory and federal requirements.
Conclusion- To conclude, any kind of research that encompasses human participants
or subjects raise complex and unique ethical, social, and legal challenges. Hence, during the
clinical simulation, all measures were adopted to show adherence to the major ethical norms
that arose in relation to data falsification, fabrication, informed consent, and IRB approval.

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References
Blackwood, R. A., Maio, R. F., Mrdjenovich, A. J., VandenBosch, T. M., Gordon, P. S.,
Shipman, E. L., & Hamilton, T. A. (2015). Analysis of the nature of IRB
contingencies required for informed consent document approval. Accountability in
research, 22(4), 237-245.
Jensen, L. B., Kyvik, K. O., Leth-Larsen, R., & Eriksen, M. B. (2018). Research integrity
among PhD students within clinical research at the University of Southern
Denmark. Clinical research, 133, 80-6.
Metcalf, J., & Crawford, K. (2016). Where are human subjects in big data research? The
emerging ethics divide. Big Data & Society, 3(1), 2053951716650211.
Nardi, P. M. (2018). Doing survey research: A guide to quantitative methods. Routledge.
Wolf, S. M., Clayton, E. W., & Lawrenz, F. (2018). The past, present, and future of informed
consent in research and translational medicine.